Quality Assurance Associate

• Sep 2023 - Present

Regulatory Affairs Specialist

• Feb 2022 - Mar 2023

Due diligence projects: • Executed Due Diligence for 22 NMPA licenses, collaborating with R&D engineers to verify parameter data and claims against internal test reports and the new regulation, identifying discrepancies to mitigate post-market risk. • Assessed the feasibility of remediation actions for identified discrepancies and collaborated with the quality assurance team to ensure timely and cost-effective compliance. • Managed and supervised worst-case sample testing, proactively communicating with testing lab engineers to resolve issues in real-time and securing necessary test reports for remediation submission. Regular maintenance of licenses: • Initially responsible for the maintenance of one product line’s NMPA licenses, later entrusted with an additional line, successfully handled multiple types of submissions. • Developed a future-focused registration plan based on marketing team's sales insights and adjusted the plan according to changes. • Tracked registration processes and maintained thorough record-keeping of all submission documents, ensuring timely communication of any changes to relevant departments. Show less